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Stryker SwitchPoint Infinity® 3 Control Systern is intended to be a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel.

This submission describes the Stryker SwitchPoint Infinity® 3 Control System intended for use as a central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as and teleconferencing for medical personnel. The system provides a user interface through which to centrally control and provide visual status of various compatible devices including surgical devices, such as through the Stryker SIDNE™ system, as well as other devices, such as audio/video equipment used by medical personnel. It also functions as a matrix router capable of dynamically routing an array of audio, video, or other data sources to an array of audio, video or other data destinations. The routing capability is used to integrate local audio/video sources and destinations within a room. The SPI3 system provides an interface to facilitate audio/video communications to other rooms within the hospital campus, as well as off-site.

The provided document is a 510(k) premarket notification for the Stryker SwitchPoint Infinity® 3 Control System. This device is described as a "central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel."

It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone AI performance as typically found in submissions for AI/ML-driven diagnostic devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance of an algorithm, and training set details are not applicable to this type of regulatory submission for this specific device.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance criteria.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided. The submission details engineering and design comparisons, not a clinical performance study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided as there is no mention of a clinical test set requiring expert ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided as there is no mention of a clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided. This device is an integration and control system, not an AI-driven diagnostic or assistive tool, so an MRMC study is not relevant to its stated purpose.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not provided. The device is an integration system and not an algorithm with standalone performance metrics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided as there is no mention of a clinical test set requiring ground truth.

8. The sample size for the training set:

This information is not provided as the device is not described as an AI/ML system that undergoes a training phase with a dataset.

9. How the ground truth for the training set was established:

This information is not provided as there is no mention of a training set.

Summary of Device and Regulatory Approach as per the Document:

• Device Name: Stryker SwitchPoint Infinity® 3 Control System (SPI3)
• Intended Use: "A central point of control and integration of ancillary compatible equipment, audio, video, and data routing, as well as teleconferencing for medical personnel." It provides a user interface to centrally control compatible devices, acts as a matrix router for audio/video/data, and facilitates audio/video communications within and outside the hospital.
• Regulatory Basis: 510(k) Premarket Notification based on demonstrating substantial equivalence to legally marketed predicate devices.
• Predicate Devices:
  • Stryker SwitchPoint Infinity Control System (K033132)
  • Olympus EndoALPHA Integrated Endosurgery System (K051613)
  • KSEA Storz Communication Bus (SCB) Media Control (K020640)
• Claim of Equivalence: The submission states that "The minor differences between the Stryker SwitchPoint Infinity® 3 Control System and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of the device." The conclusion is that it "does not raise any new safety or efficacy issues" based on "applicable testing and the equivalence information presented." (The details of this "applicable testing" are not provided in the excerpt, but typically include device verification and validation activities showing it meets its own design specifications and functions as intended, not a comparative clinical study).

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The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room. The intent of the Switchpoint Infinity™ Control System is to allow operating room personnel a center point for controlling all equipment and communication in surgery.

The Stryker Switchpoint Infinity™ Control System is indicated for use with the Stryker Endoscopy Sidne™ System [510(k) # K022393] and Sidne™ compatible endoscopic and general surgery devices. The users of Switchpoint Infinity™ Control System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, urologists, and any other surgeon whom requires the use of voice, video, or control in the operating room or a teleconferencing interface.

The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room.

The provided text is a 510(k) summary for the Stryker Switchpoint Infinity™ Control System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, expert adjudication, or sample sizes related to performance evaluation.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study data in the way a clinical trial or a standalone AI algorithm validation would.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance study details from the provided text.

The document states:

"The technological differences between the Stryker Switchpoint Infinity™ Control System and the predicate devices (Sidne™ System, Nurse's Assistant OR Control System, Switchpoint™ III, and KSEA Storz Communication Bus (SCB) Media Control™) do not raise new issues of safety and efficacy. Therefore, the Stryker Switchpoint Infinity™ Control System is substantially equivalent to the currently marketed Sidne™ System, Nurse's Assistant OR Control System, Switchpoint™ III, and KSEA Storz Communication Bus (SCB) Media Control™."

This declaration of substantial equivalence, along with conformity to voluntary standards (UL 60601-1, EN 60601-1-2), is the "proof" the device meets the safety and effectiveness requirements for 510(k) clearance, as opposed to a specific performance study with acceptance criteria.

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